RA / QA Manager – Medical Software

Location:

Ghent – Flanders, Belgium

Salary:

Negotiable

Type:

Permanent

Main Industry:

Search Science Jobs

Other Industries & Skills: 

Biomedical Transport, Logistics & Distribution

Advertiser:

NonStop Consulting

Job ID:

131658116

Posted On: 

06 March 2025

RAQA Manager – Medical Devices

Our client, a small MedTech company located in Ghent, Belgium, is currently seeking a highly experienced and motivated RAQA Manager to join their team. With a focus on taking on the challenge of regulatory compliance for medical devices for FDA approval, this role offers the unique opportunity to make your mark on the department and create a tailored work environment.

As an integral part of the organisation, you will have the opportunity to work closely with decision makers and colleagues, leading to fast approval times and quick feedback. The close-knit nature of the team allows for a collaborative working environment, where your ideas and inputs can directly contribute to the company’s success.

Benefits:

– Manage and build a Regulatory team, putting your own stamp on the department
– Hybrid function with flexible hours, allowing you to find your own rhythm of activity
– Less micro-management and more control over your own work-life balance

Responsibilities:

– Planning and monitoring clinical evaluation & validation, track and maintain requirements in line with medical device regulation
– Lead and manage the Regulatory Affairs activities, ensuring compliance with applicable regulations and standards
– Collaborate with cross-functional teams to provide expertise and support in all aspects of Quality Assurance and Regulatory Affairs

Requirements:

– Degree in Pharmacy, Biological or Chemical sciences, Engineering or equivalent, with a minimum of 8 years of work experience within the medical device industry in Quality and/or Regulatory
– Fluent in both English and Dutch. French language proficiency is an added value
– 3+ years of experience within an RA environment for medical devices
– Proficient understanding of ISO 13485, ISO 14155, Regulation (EU) 2017/745

If this role suits your personal and professional profile, send your CV to myself, Christian Finnegan ( # ), on the NonStop consulting website or to my LinkedIn. If you yourself are not interested in this opportunity however you know someone whom might be interested in a new role, please forward this job posting to them and help them expand their network.

NonStop is one of the largest and fastest growing specialised life-sciences & Med-tech recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Switzerland, Romania, Luxembourg, France, US and the Czech Republic and we hold labour leasing licences for all EU8 countries. our website for a full list of the niche markets we cover.

To help us track our recruitment effort, please indicate in your email/cover letter where (vacanciesin.eu) you saw this job posting.